ADHDQUOTANCT03368573
QbTest Utility for Optimising Treatment in ADHD (QUOTA)
A study testing QbTest in people with ADHD, run by Nottinghamshire Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
Attention Deficit/Hyperactivity Disorder (ADHD) is a condition that affects 3-5% of young people under 18-years-old. Young people with ADHD have difficulties with attention, impulsivity and hyperactivity that make it harder for them to learn, form relationships and prepare for adulthood. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- ADHD
- What is being tested?
- QbTest
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2017to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or Female, aged 6-17 years (at the time of consent).
- Participant is willing and able to give informed consent for participation in the study (if over 16-years).
- Parental consent for children and young people aged under 16-years-old.
- Referred to CAMHS or Community Pediatric services and diagnosed with ADHD.
- Clinician and family (parent/carer and young person/child) agreement to commence stimulant medication for ADHD symptoms.
Who cannot join
- Unable to give informed consent
- Severe learning difficulty
- Not started on stimulant medication (either not started on medication at all or started on a non-stimulant medication)
- Non-fluent English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottinghamshire Healthcare NHS Foundation Trust
Nottingham, NG3 6AA
About this study
Official title: Optimising Medication Management in Children and Young People With Attention Deficit Hyperactivity Disorder (ADHD) Using an Objective Measure of Attention, Impulsivity and Activity (QbTest): a Feasibility Study
Attention Deficit/Hyperactivity Disorder (ADHD) is a condition that affects 3-5% of young people under 18-years-old.
Young people with ADHD have difficulties with attention, impulsivity and hyperactivity that make it harder for them to learn, form relationships and prepare for adulthood. Clinical guidelines state that young people taking medication for ADHD should be closely monitored and have their medication reviewed regularly to ensure they receive the correct dose to improve their symptoms. However, many young people aren't monitored as closely as guidelines recommend. This can lead to lack of improvement or worsening of symptoms meaning that children may not experience the benefits of medication as quickly as they should. At the moment, assessing whether or not medication is working relies on the opinions of teachers and parents, collected through questionnaires. The difficulties of this are: differences of opinion between people, lack of information provided by them, and not returning the questionnaires. A test performed on a computer (QbTest) provides doctors with a report of the young person's symptoms and can therefore show whether medication is working. This may help doctors reach accurate decisions about medication dose more quickly, reducing the need for questionnaires. The study team met with families and young people with ADHD and medical experts and developed a procedure for using QbTest to measure medication effects. The study team will measure how well this procedure works in the real world by asking a group of young people to complete the test when they first start taking medication and at their follow-up appointments. The study team will ask doctors and families/young people for their opinions on the procedure.
The study team shall share our findings with other researchers and with the public by attending local support groups and providing summaries of the study results. The findings will be used to prepare for a future study.
Read the detailed description
The primary objective of the study is to assess the feasibility and acceptability of the study design using a feasibility RCT.
The end-points to assess this objective are:
- Acceptability of randomisation. The number of patients who do not participate and state randomisation as the reason for non-participation. The study team shall also monitor drop-out rates immediately after randomisation and the number of errors in randomisation at each site.
- Acceptability of study design. The number of eligible patients at each site and the numbers who consent to take part/withdraw. Withdrawal rates will be recorded alongside time point in the trial to ascertain acceptability of the study duration.
- Acceptability of outcome measures. Completion rates for outcomes to determine most appropriate methods of data collection.
- Acceptability/feasibility of protocol. Record non-adherence of healthcare professionals to the protocol and explore reasons.
- Feasibility of future RCT. Estimate the hours per week needed to run the RCT and therefore the number of research assistants/fellows required and time commitment required by HCPs.
- Conditions
- ADHD
- Being tested
- QbTest
- Keywords
- ADHD, Cognitive Assessment, QbTest, Medication, Feasibility
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QbTestDevice
QbTest is a computerised assessment which takes approximately 20mins. The test combines a continuous performance test alongside an infrared camera which measures the participant's movements. The infrared camera measures motor activity of the participant whilst they undertake the task. During the test, the participant is presented with continuously changing stimuli. Embedded within these stimuli is a given target. Participants have to respond by pressing a hand-held button only when the target appears. Attention is measured through omission errors and reaction time to response. Impulsivity is assessed through commission errors and anticipatory errors. Motor activity is measured through head movements during the task. The test is approved by the FDA (Ref: K133382) and CE marked.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Participants in the control arm will undergo standard treatment as usual for ADHD. This will involve the clinician reviewing the child's symptom improvement once on medication and altering the dose according to their clinical judgement which may be informed by rating scales (completed by the parent, teacher and/or young person) and interviews with the parent and young person. |
| Experimental Arm | Experimental | Participants in the experimental arm (QbTest) protocol will also undergo standard assessment as usual plus a QbTest. If a QbTest was not conducted within 12 weeks prior to starting medication (as part of the ADHD diagnostic assessment procedure) the young person will sit a QbTest at baseline (off medication). Once on medication they will sit another QbTest 2-4 weeks after commencing medication and again 8-10 weeks later (and no later than 12 weeks). Receives: Device: QbTest |
What is being measured
The primary outcome is the main question the study is designed to answer.
SNAP-IV
SNAP-IV is a short questionnaire designed to assess ADHD symptoms, with established validity, reliability and use in clinical and research settings. Completed by Parents and Teachers.
Measured: Follow up 2 (8-10 weeks)
Secondary outcomes (7)
SDQ
The SDQ is a short, well validated and well used clinical and research measure that assesses a range of behavioural and emotional issues in children and young people. Completed by parents and teachers.
Measured: Baseline (0 weeks), Follow up 2 (8-10 weeks)
CHU9D
a short (5 minute) measure of quality of life. The CHU9D has been designed for use with children and young people and is very easy to complete
Measured: Baseline (0 weeks), Follow up 1 (2-4 weeks), Follow up 2 (8-10 weeks)
CGI (Clinical Global Impressions Scale)
Clinicians will be asked to complete the CGI. The CGI takes no longer than 5 minutes to complete and measures symptom severity and improvement due to medication.
Measured: Baseline (0 weeks), Follow up 2 (8-10 weeks)
Health Economic Outcome
Measure of use of Health Services
Measured: Follow up 2 (8-10 weeks)
Side Effects Questionnaire
To measure medication side effects
Measured: Follow up 1 (2-4 weeks) and Follow up 2 (8-10 weeks)
Medication adherence
To look adherence to medication
Measured: Follow up 1 (2-4 weeks) and Follow up 2 (8-10 weeks)
Qualitative Interviews
To look at the acceptability of the intervention
Measured: Follow up 2 (8-10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start1 Dec 2017
- Primary completion31 Mar 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants in the experimental arm (QbTest) protocol will also undergo standard assessment as usual plus a QbTest. If a QbTest was not conducted within 12 weeks prior to starting medication (as part of the ADHD diagnostic assessment procedure) the young person will sit a QbTest at baseline (off medication). Once on medication they will sit another QbTest 2-4 weeks after commencing medication and again 8-10 weeks later (and no later than 12 weeks). Participants in the control arm will undergo standard treatment as usual for ADHD. This will involve the clinician reviewing the child's symptom improvement once on medication and altering the dose according to their clinical judgement which may be informed by rating scales (completed by the parent, teacher and/or young person) and interviews with the parent and young person.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottinghamshire Healthcare NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368573
- Sponsor's protocol ID
- PB-PG-1215-20026
- Acronym
- QUOTA
- Status last verified
- Dec 2017
- First submitted
- 22 Nov 2017
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Williams L, Hall CL, Brown S, Guo B, James M, Franceschini M, Clarke J, Selby K, Vijayan H, Kulkarni N, Brown N, Sayal K, Hollis C, Groom MJ. Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial. Pilot Feasibility Stud. 2021 Mar 16;7(1):68. doi: 10.1186/s40814-021-00788-1.
PubMed 33726855Hall CL, Brown S, James M, Martin JL, Brown N, Selby K, Clarke J, Williams L, Sayal K, Hollis C, Groom MJ. Consensus workshops on the development of an ADHD medication management protocol using QbTest: developing a clinical trial protocol with multidisciplinary stakeholders. BMC Med Res Methodol. 2019 Jun 18;19(1):126. doi: 10.1186/s12874-019-0772-2.
PubMed 31215440Hall CL, James M, Brown S, Martin JL, Brown N, Selby K, Clarke J, Vijayan H, Guo B, Sayal K, Hollis C, Groom MJ. Protocol investigating the clinical utility of an objective measure of attention, impulsivity and activity (QbTest) for optimising medication management in children and young people with ADHD 'QbTest Utility for Optimising Treatment in ADHD' (QUOTA): a feasibility randomised controlled trial. BMJ Open. 2018 Feb 15;8(2):e021104. doi: 10.1136/bmjopen-2017-021104.
PubMed 29453304
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Medication Management in Children and Young People With Attention Deficit Hyperactivity Disorder (ADHD) Using an Objective Measure of Attention, Impulsivity and Activity (QbTest): a Feasibility Study
- ClinicalTrials.gov ID
- NCT03368573
- Acronym / sponsor ID
- QUOTA / PB-PG-1215-20026
- Conditions
- ADHD
- Keywords
- ADHD, Cognitive Assessment, QbTest, Medication, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Nottinghamshire Healthcare NHS TrustOther government
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Attention Deficit/Hyperactivity Disorder (ADHD) is a condition that affects 3-5% of young people under 18-years-old.
Young people with ADHD have difficulties with attention, impulsivity and hyperactivity that make it harder for them to learn, form relationships and prepare for adulthood. Clinical guidelines state that young people taking medication for ADHD should be closely monitored and have their medication reviewed regularly to ensure they receive the correct dose to improve their symptoms. However, many young people aren't monitored as closely as guidelines recommend. This can lead to lack of improvement or worsening of symptoms meaning that children may not experience the benefits of medication as quickly as they should. At the moment, assessing whether or not medication is working relies on the opinions of teachers and parents, collected through questionnaires. The difficulties of this are: differences of opinion between people, lack of information provided by them, and not returning the questionnaires. A test performed on a computer (QbTest) provides doctors with a report of the young person's symptoms and can therefore show whether medication is working. This may help doctors reach accurate decisions about medication dose more quickly, reducing the need for questionnaires. The study team met with families and young people with ADHD and medical experts and developed a procedure for using QbTest to measure medication effects. The study team will measure how well this procedure works in the real world by asking a group of young people to complete the test when they first start taking medication and at their follow-up appointments. The study team will ask doctors and families/young people for their opinions on the procedure.
The study team shall share our findings with other researchers and with the public by attending local support groups and providing summaries of the study results. The findings will be used to prepare for a future study.
Detailed description
The primary objective of the study is to assess the feasibility and acceptability of the study design using a feasibility RCT.
The end-points to assess this objective are:
- Acceptability of randomisation. The number of patients who do not participate and state randomisation as the reason for non-participation. The study team shall also monitor drop-out rates immediately after randomisation and the number of errors in randomisation at each site.
- Acceptability of study design. The number of eligible patients at each site and the numbers who consent to take part/withdraw. Withdrawal rates will be recorded alongside time point in the trial to ascertain acceptability of the study duration.
- Acceptability of outcome measures. Completion rates for outcomes to determine most appropriate methods of data collection.
- Acceptability/feasibility of protocol. Record non-adherence of healthcare professionals to the protocol and explore reasons.
- Feasibility of future RCT. Estimate the hours per week needed to run the RCT and therefore the number of research assistants/fellows required and time commitment required by HCPs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants in the experimental arm (QbTest) protocol will also undergo standard assessment as usual plus a QbTest. If a QbTest was not conducted within 12 weeks prior to starting medication (as part of the ADHD diagnostic assessment procedure) the young person will sit a QbTest at baseline (off medication). Once on medication they will sit another QbTest 2-4 weeks after commencing medication and again 8-10 weeks later (and no later than 12 weeks). Participants in the control arm will undergo standard treatment as usual for ADHD. This will involve the clinician reviewing the child's symptom improvement once on medication and altering the dose according to their clinical judgement which may be informed by rating scales (completed by the parent, teacher and/or young person) and interviews with the parent and young person.
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Participants in the control arm will undergo standard treatment as usual for ADHD. This will involve the clinician reviewing the child's symptom improvement once on medication and altering the dose according to their clinical judgement which may be informed by rating scales (completed by the parent, teacher and/or young person) and interviews with the parent and young person. |
| Experimental Arm | Experimental | Device: QbTestParticipants in the experimental arm (QbTest) protocol will also undergo standard assessment as usual plus a QbTest. If a QbTest was not conducted within 12 weeks prior to starting medication (as part of the ADHD diagnostic assessment procedure) the young person will sit a QbTest at baseline (off medication). Once on medication they will sit another QbTest 2-4 weeks after commencing medication and again 8-10 weeks later (and no later than 12 weeks). |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or Female, aged 6-17 years (at the time of consent).
- Participant is willing and able to give informed consent for participation in the study (if over 16-years).
- Parental consent for children and young people aged under 16-years-old.
- Referred to CAMHS or Community Pediatric services and diagnosed with ADHD.
- Clinician and family (parent/carer and young person/child) agreement to commence stimulant medication for ADHD symptoms.
Key exclusion criteria (4 listed)
- Unable to give informed consent
- Severe learning difficulty
- Not started on stimulant medication (either not started on medication at all or started on a non-stimulant medication)
- Non-fluent English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QbTestQbTest is a computerised assessment which takes approximately 20mins. The test combines a continuous performance test alongside an infrared camera which measures the participant's movements. The infrared camera measures motor activity of the participant whilst they undertake the task. During the test, the participant is presented with continuously changing stimuli. Embedded within these stimuli is a given target. Participants have to respond by pressing a hand-held button only when the target appears. Attention is measured through omission errors and reaction time to response. Impulsivity is assessed through commission errors and anticipatory errors. Motor activity is measured through head movements during the task. The test is approved by the FDA (Ref: K133382) and CE marked. | Device | Experimental Arm |
Primary outcome
SNAP-IV
Time frame: Follow up 2 (8-10 weeks)
SNAP-IV is a short questionnaire designed to assess ADHD symptoms, with established validity, reliability and use in clinical and research settings. Completed by Parents and Teachers.
7 secondary outcomes
SDQ
Time frame: Baseline (0 weeks), Follow up 2 (8-10 weeks)
CHU9D
Time frame: Baseline (0 weeks), Follow up 1 (2-4 weeks), Follow up 2 (8-10 weeks)
CGI (Clinical Global Impressions Scale)
Time frame: Baseline (0 weeks), Follow up 2 (8-10 weeks)
Health Economic Outcome
Time frame: Follow up 2 (8-10 weeks)
Side Effects Questionnaire
Time frame: Follow up 1 (2-4 weeks) and Follow up 2 (8-10 weeks)
Medication adherence
Time frame: Follow up 1 (2-4 weeks) and Follow up 2 (8-10 weeks)
Qualitative Interviews
Time frame: Follow up 2 (8-10 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Derived from this study: PubMed 33726855Williams L, Hall CL, Brown S, Guo B, James M, Franceschini M, Clarke J, Selby K, Vijayan H, Kulkarni N, Brown N, Sayal K, Hollis C, Groom MJ. Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial. Pilot Feasibility Stud. 2021 Mar 16;7(1):68. doi: 10.1186/s40814-021-00788-1.
- Derived from this study: PubMed 31215440Hall CL, Brown S, James M, Martin JL, Brown N, Selby K, Clarke J, Williams L, Sayal K, Hollis C, Groom MJ. Consensus workshops on the development of an ADHD medication management protocol using QbTest: developing a clinical trial protocol with multidisciplinary stakeholders. BMC Med Res Methodol. 2019 Jun 18;19(1):126. doi: 10.1186/s12874-019-0772-2.
- Derived from this study: PubMed 29453304Hall CL, James M, Brown S, Martin JL, Brown N, Selby K, Clarke J, Vijayan H, Guo B, Sayal K, Hollis C, Groom MJ. Protocol investigating the clinical utility of an objective measure of attention, impulsivity and activity (QbTest) for optimising medication management in children and young people with ADHD 'QbTest Utility for Optimising Treatment in ADHD' (QUOTA): a feasibility randomised controlled trial. BMJ Open. 2018 Feb 15;8(2):e021104. doi: 10.1136/bmjopen-2017-021104.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QbTest in people with ADHD, run by Nottinghamshire Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SNAP-IV (time frame: Follow up 2 (8-10 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03368573, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.